510(k) Report

FDA applicant

Trokamed GmbH

Geisingen, DE4 decisions2006–202115 recalls

FDA records 4 decisions for Trokamed GmbH (Geisingen, DE) from 2006 to 2021: 4 510(k) clearances. Most are in product codes FED (Endoscopic Access Overtube…) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 14 predicates, 0 of them its own earlier devices. 15 recalls are linked to its devices, 4 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, gastroenterology and urology panel, where it files most

How often FDA has decided Trokamed GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2011: 12021: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

4in 2024

2014: 112024: 4, 4 Class I
2007high 11 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Trokamed GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Trokamed GmbH’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FEDEndoscopic Access Overtube, Gastroenterology-Urology1decision
  • GCJLaparoscope, General & Plastic Surgery1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • HETLaparoscope, Gynecologic (And Accessories)1decision

Whose devices does it build on?

Its devices cite 14 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060232Trokamed GMBH Electrosurgical Instruments & AccessoriesTrokamed GmbH · 20061cites it

What has FDA decided for it lately?

  • K200770Mini PCNL-SystemTrokamed GmbH · 20214 Class I recalls
  • K091010Trokamed MorcellatorTrokamed GmbH · 20111 recall
  • K060233Trokamed GMBH Endoscopes and AccessoriesTrokamed GmbH · 2006
  • K060232Trokamed GMBH Electrosurgical Instruments & AccessoriesTrokamed GmbH · 200610 recalls

All 4 as Trokamed GmbH →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K200770Sheath, 18 Fr., 130 mm (REF: WA2PS18S), gastroenterology-urology endoscopic access…Nov 27, 2024Class I
  • K200770Sheath, 20 Fr., 130 mm (REF: WA2PS20S), gastroenterology-urology endoscopic access…Nov 27, 2024Class I
  • K200770Sheath, 20 Fr., 160 mm (REF: WA2PS20L), gastroenterology-urology endoscopic access…Nov 27, 2024Class I
  • K200770Sheath, 18 Fr., 160 mm (REF: WA2PS18L), gastroenterology-urology endoscopic access…Nov 27, 2024Class I
  • K091010Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic…Jul 16, 2014Class II
  • K060232Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and…May 30, 2014Class II